Hepatocellular Carcinoma
Conditions
Brief summary
This is an open label, multi-center, single arm study to evaluate the efficacy and safety of tislelizumab combined with sitravatinib as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.
Detailed description
Hepatocellular carcinoma (HCC) is a malignant tumor with high morbidity and mortality. Surgical resection is the most important radical treatment. However, the recurrence rate is high especially in the patients with high risk of recurrence after curative resection. How to reduce postoperative recurrence and improve survival is currently a direction that is worth exploring. Until now there is no standard postoperative adjuvant therapy. Various adjuvant treatment methods including immunotherapy, targeted therapy, TACE are being studied. This study is to explore the efficacy and safety of tislelizumab combined with sitravatinib as adjuvant therapy in HCC patients who are at high risk of recurrence after curative resection.
Interventions
DRUGTislelizumab + Sitravatinib
Drug: Tislelizumab Tislelizumab 200mg IV q3w Other Names: BGB-A317, Immunotherapy, Anti-PD-1 antibody Drug: Sitravatinib Sitravatinib 100mg PO qd Other Name: tyrosine kinase inhibitor, TKI
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
First Affiliated Hospital of Guangxi Medical University
Henan Cancer Hospital
Anhui Provincial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects with a histopathological or cytologically diagnosis of HCC 2. Subjects who have undergone a curative resection 3. High risk for HCC recurrence as protocol defined 4. No previous systematic treatment and locoregional therapy for HCC 5. Child-Pugh Score, Class A 6. ECOG performance status 0 or 1 7. Full recovery from surgical resection 8. Adequate organ function 9. Absence of major macrovascular invasion 10. No extrahepatic spread 11. Life expectancy of at least 6 months
Exclusion criteria
1. Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC 2. Evidence of residual, recurrent, or metastatic disease 3. Known history of serious allergy to any component of tislelizumab or sitravatinib preparations 4. History of hepatic encephalopathy 5. Tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein 6. Portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment 7. Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment 8. Any active malignancy within 2 years prior to the start of treatment 9. Active or history of autoimmune disease 10. Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation 11. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RFS rate | Observation period 24 months | 2-year Recurrence Free Survival Rate (2-year RFS rate) \[Time Frame: Observation period 24 months\] 2-year RFS rate is defined as the proportion of patients alive and free of recurrence at 2 years after curative resection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RFS | 24 months | 2.Recurrence-Free Survival (RFS) \[Time Frame: 24 months\] RFS is defined as the time from the date of curative resection to the first documented recurrenceor death due to any cause, whichever occurs first. |
| RFS rate | 12 months | 3.1-year RFS rate \[Time Frame: 12 months\] 1-year RFS rate is defined as the proportion of patients alive and free of recurrence at 1 yearsafter curative resection. |
| TTR | 24 months | 1.Time to recurrence (TTR) \[Time Frame: 24 months\] TTR is defined as the time from the date of curative resection to the first documented recurrence. |
| OS rate | 12 months/24 months | 5.1-year OS rate/2-year OS rate \[Time Frame: 12 months/24 months\] OS rate is defined as the proportion of patients who have not experienced death from any causeat 12 and 24 months after curative resection. |
| AEs | 24 months | 6.Adverse Events (AEs) \[ Time Frame: 24 months \] The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0 |
| OS | 24 months | 4.Overall Survival (OS）\[Time Frame: 24 months\] OS is defined as the time from the date of curative resection until death due to any cause. |
Countries
China
Contacts
Primary ContactLianxin LIU secretary of the party committee
Backup ContactJiabei WANG None
Outcome results
None listed